Comparing the Efficacy of Different Zinc Formulations in the Treatment of Diarrhea
NCT ID: NCT00682955
Last Updated: 2008-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2007-08-31
2008-04-30
Brief Summary
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Detailed Description
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The intervention study will be undertaken in hospital based settings. A total recruitment of 300(150 each in each group) has been targetted during the study duration. The duration of this study shall be 9 months.
A brief history will be taken regarding the current illness and will be noted down in the specific forms. After the history the patient will be completely examined by the duty doctors, examination will emphasize of the vitals, status of dehydration and anthropometry. Patient will then be randomized in one of the groups and the procedure of using Zinc tablets or suspension will be explained to the mother or caretaker.The patient will be advised treatment according to the general condition and state of the dehydration and general health. All treatments will be noted down in the specific forms to have a record of what have been given to the patient and to keep the record of fluid intake. Stool samples for the detailed report and culture and sensitivity will be collected \& sent to have the information regarding the status of stool and any isolated organism.
Follow-ups
* The patients will be followed \& examined thoroughly every 8 hourly till the time of discharge by a trained RMO.
* At each follow up, details of illness characteristics, including the number and character of stools and vomiting, will be obtained.
* Information regarding the associated symptoms including fever, abdominal pain distension and dysentery will be obtained. Hydration status, vitals and weight will also be assessed.
* RMO will record about the proper dosages of zinc and confirm that weather or not patient is taking his medications during every follow up
* RMO will also document the recovery of diarrhea in terms of reduction in frequency and duration of diarrhoea and all the information will be noted in the assigned follow up forms.
* Any adverse effect of the associated with the Zinc will also be recorded.
* Compliance will be measured by reported intake and by measuring the remaining volume of syrup in the returned bottles and number of tablets used in the blisters.
* At the time of discharge a discharge summary form is also filled by RMO
* The patients who will be discharged will be followed at home for a total of two weeks of illness.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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B
This group has been given Zinc Sulphate in Suspension Form.
Zinc Sulphate
20 mg per day of Zinc Sulphate in suspension form has been given to subjects.
A
This group has been given Tablets of Zinc Sulphate.
Zinc Sulphate
20 mg per day, Zinc Sulphate tablet has been given to subjects.
Interventions
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Zinc Sulphate
20 mg per day, Zinc Sulphate tablet has been given to subjects.
Zinc Sulphate
20 mg per day of Zinc Sulphate in suspension form has been given to subjects.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presented with passage of 3 or more loose or watery stools
* Caretakers are willing to let their child to participate in the study.
Exclusion Criteria
* Children with severe malnutrition or having chronic illness
6 Months
5 Years
ALL
No
Sponsors
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Civil Hospital, Hyderabad, Pakistan
UNKNOWN
National Institute of Child Health, Karachi, Pakistan
OTHER_GOV
Aga Khan University
OTHER
Responsible Party
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The Aga Khan University
Locations
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Civil Hospital
Hyderābād, Sindh, Pakistan
National Institute of Child Health
Karachi, Sindh, Pakistan
Countries
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Other Identifiers
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857-PED/ERC-07
Identifier Type: -
Identifier Source: org_study_id